Testing equipment with magnifying function

ABSTRACT

Embodiments disclose a device for testing biological specimen. The device includes a sample carrier and a detachable cover. The sample carrier includes a specimen holding area. The detachable cover is placed on top of the specimen holding area. The detachable cover includes a magnifying component configured to align with the specimen holding area. The focal length of the magnifying component is from 0.1 mm to 3 mm. The magnifying component has a magnification ratio of at least 30.

FIELD OF THE INVENTION

The invention relates to equipment for testing biological specimen, andrelates particularly to testing equipment with a magnifying function.

BACKGROUND OF THE INVENTION

Currently, testing of liquid contents, are typically consigned toprofessional testing authorities for performing testing using expensivemicroscope equipment with high magnification ratios. Since an individualdoes not have microscope equipment, the testing activity cannot beperformed by the individual.

However, in some testing categories nowadays testing is required to beperformed on a regular basis; therefore the need for frequent testingposes an excessive burden in terms of time and expense. For example, thecategory of long term testing includes semen testing for patients withinfertility issues. The semen testing is mainly directed to performingobservations on the number of sperms, their motility and morphology.

The semen testing method involves resting semen of a male subject at aroom temperature for a period of time, and taking a drop of the sampleand instilling the sample to a slide, and observing the sample under amicroscope. The observations not only include performing highmagnification observation of individual sperm to identify the externalappearance of individual sperm, but also include performing observationsof overall sperms in a large quantity, their motility, morphology andthe quantity per unit area. However, an individual cannot perform thesemen testing by himself because the industry have not yet developed atechnology that allows an individual to perform testing through a simpleaiding device.

SUMMARY OF THE INVENTION

The invention provides a testing equipment with magnifying function,which is significantly less expensive than conventional testingequipment, requires less labor for testing, and is easy to use. Thetechnology can be applied to semen testing, as well as other testingareas such as micro-organisms in water, water quality, and skinepidermis tissues/cells. The technology provides a simple testingproduct with significantly lower usage cost than convention techniquesusing laboratory microscope equipment.

Comparing to the conventional techniques, the testing equipment withmagnifying function disclosed herein provides a simple structure thatcan significantly lower the cost of specimen magnifying testingstructure, for tests such as sperm test or urinalysis. The technologydisclosed herein can be used in a wide range of applications, throughthe design of the carrier having the specimen holding area, themagnifying part and the unique innovative configuration. For example,the testing equipment with magnifying function can be applied to inspectthe counts, the motility and the morphology of sperm specimen.

The testing equipment with magnifying function of the invention issuitable for performing tests at home. The results of the test can beobtained instantly and the cost is low. For example, the testingequipment with magnifying function provides a way to assess malefertility at home for couples seeking pregnancy so that the couples canmake an informed decision whether medical intervention is needed.

The disclosed technology can be conveniently integrated with existingintelligent communications device (such as smart phone or tablet), andenables the use of existing intelligent communications device to capturemagnified testing images and perform subsequent operations such asstoring and transferring the images. The cost of the devices is low sothat the devices can be implemented as disposable devices or reusabledevices.

At least some embodiments of the present invention are directed to adevice for testing biological specimen. The device includes a samplecarrier and a detachable cover. The sample carrier includes a specimenholding area. The detachable cover is placed on top of the specimenholding area. The detachable cover includes a magnifying componentconfigured to align with the specimen holding area. The focal length ofthe magnifying component is from 0.1 mm to 3 mm. The magnifyingcomponent has a magnification ratio of at least 30.

At least some embodiments of the present invention are directed to asystem for testing biological specimen. The system includes the devicefor testing biological specimen mentioned above and a base component.The base component includes an insertion port for inserting the devicefor testing biological specimen into the base component. The basecomponent further includes a camera component for capturing the image ofthe specimen holding area, or a form-fitting frame for securing a mobiledevice that includes a camera component for capturing the image of thespecimen holding area.

At least some embodiments of the present invention are directed to amethod for testing sperms using the device for testing biologicalspecimen. The method includes steps of: obtaining the device, applying asperm specimen to the specimen holding area, recording a video or animage of the sperm specimen; determining the sperm count of the spermspecimen based on the at least one frame of the recorded video or therecorded image; and determining the sperm motility of the sperm specimenbased on the recorded video or the recorded image.

At least some embodiments of the present invention are directed to amethod for testing sperms using the system. The method includes stepsof: receiving a device inserted into the base component; recording avideo of the sperm specimen in the specimen holding area by a mobiledevice, the mobile device being secured in the form-fitting frame of thebase component; determining a sperm count of the sperm specimen based onthe at least one frame of the recorded video; and determining a spermmotility of the sperm specimen based on the recorded video.

Reference will now be made in detail to the present preferredembodiments of the invention, examples of which are illustrated in theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an exploded view of a testing equipment with magnifyingfunction according to an embodiment of the invention.

FIG. 1B is an assembled view of the testing equipment of FIG. 1A.

FIG. 2A is a cross-sectional view of the testing equipment of FIG. 1A.

FIG. 2B is a cross-sectional view of another embodiment of testingequipment.

FIG. 3 is a flow diagram of testing for a testing equipment according toan embodiment of the invention.

FIG. 4 is a cross-sectional view of a testing equipment with magnifyingfunction according to another embodiment of the invention.

FIG. 5 is a cross-sectional view of a testing equipment with magnifyingfunction according to another embodiment of the invention.

FIG. 6 is a schematic diagram of the testing equipment of FIG. 5 beingused.

FIG. 7 is a schematic diagram of a testing equipment with magnifyingfunction according to another embodiment of the invention.

FIG. 8 is a schematic diagram of a testing equipment with magnifyingfunction according to another embodiment of the invention.

FIG. 9 is a schematic diagram of a testing equipment with magnifyingfunction according to another embodiment of the invention.

FIG. 10 is a schematic diagram of a testing equipment with magnifyingfunction according to another embodiment of the invention.

FIGS. 11-13 are views of testing equipment with magnifying functionaccording to another three embodiments of the invention.

FIG. 14A is a schematic diagram of a test strip inserted into a meterdevice according to another embodiment of the invention.

FIG. 14B is a schematic diagram of components of a meter deviceaccording to another embodiment of the invention.

FIG. 15 illustrates a sample process of a semen test by device such as ameter device or an intelligent communications device.

FIG. 16 illustrates a sample process of determining sperm concentration.

FIG. 17 illustrates sample sperms and sample sperm trajectories.

FIG. 18 illustrates a sample process of determining sperm trajectoriesand motility.

DESCRIPTION OF THE EMBODIMENTS

FIGS. 1A and 1B illustrate a testing equipment with magnifying functionaccording to an embodiment of the invention. Embodiments disclosedherein are used for illustration purpose and should not be construed asrequired limitation to the invention. The testing equipment withmagnifying function A1 includes: a carrier 10 having a specimen holdingarea 11 formed on top of the carrier 10, a cover 20 stacked on top ofthe carrier 10, and at least one magnifying part 30 (also referred to asmagnifying component or magnifier) including a convex lens type surfaceformed on the cover 20.

The magnifying part 30 of the present embodiment includes a planarconvex lens as illustrated in FIG. 1A. However, other type of magnifyinglens, e.g., a dual-sided lenticular lens can be included as themagnifying part 30. The magnifying part 30 is disposed to be alignedwith and to cover the specimen holding area 11 of the carrier 10. Themagnifying part 30 may have various magnification ratios based ontesting requirements of various tests. For example, the tests caninclude semen test, urine test, synovial joint fluid test,dermatological test, water test, etc.

A test using the testing equipment A1 with magnifying function of thepresent embodiment does not require additional magnifying lens orlaboratory microscopes, which are expensive and time-consuming tooperate. Furthermore, there is no needed to align the specimen holdingarea with the magnifying lens or laboratory microscopes.

As illustrated in FIG. 1A, the specimen holding area 11 of the carrier10 may be formed with a dented configuration. The dented configurationdesign provides a stable and large storage space containing a specimen40. The dented configuration allows the specimen to rest for a requiredperiod of time before performing the testing. For example, beforeperforming a motility testing on a semen specimen, it is necessary torest the semen specimen in a room temperature for a required period oftime before performing the motility testing.

The specimen 40 can be first instilled in the dented configuration,i.e., the specimen holding area 11 of the carrier 10 to rest for aperiod of time. As shown in FIG. 1B, a total area of the cover 20 can besmaller than a total area of the carrier 10. A specimen receiving port12 exposed outside the cover 20 is formed on one side of the specimenholding area 11. The specimen receiving port 12 can be designed to havea shape expanding outwards, which can help smoothly instilling thespecimen.

FIG. 2A shows an air channel 13 that extends beyond the other side ofthe cover 20 and is formed on the other side of the specimen holdingarea 11. The air channel 13 may prevent air filling the inside of thespecimen holding area 11, which prevent receiving of the specimen whenthe specimen is in a liquid status.

As shown in FIG. 2A, a lateral illumination device 50 can be disposed atone side of the carrier 20 of testing equipment A1. The lateralillumination device 50 can provide illumination for the specimen 40 inthe specimen holding area 11 and therefore improve resolution of thecaptured testing images of the specimen 40. In some embodiments, thespecimen holding area 11 can receive illustration from light source(s)on the top of or at the bottom of the testing equipment A1.

As illustrated in FIG. 1A, the magnifying part 30 and the cover 20 maybe integrally formed, i.e., the magnifying part 30 and the cover 20 canbe a single component. In other embodiments such as the embodimentillustrated in FIG. 2B, the detachable cover 20 and the magnifyingcomponent 30, which is disposed in the recess 21 of detachable cover 20,can each be separate components that are adapted to be integratedtogether. In other words, the same type of detachable cover 20 can beintegrated with different magnifying components 30 of variousmagnification ratios.

In some embodiments, the distance between the bottom of the detachablecover 20 and the specimen holding area 11 is from 0.005 mm to 10 mm. Insome embodiments, the distance between the bottom of the detachablecover 20 and the specimen holding area 11 is about 0.01 mm. The testingequipment can include one or more spacers (not shown) to ensure thedistance between the bottom of the detachable cover 20 and the specimenholding area 11. The spacer(s) can integrally formed with the detachablecover 20 or the specimen holding area 11 of the carrier 10.

In some embodiments, the strip including the carrier 10 and the cover 20is for sperm test. In some embodiments, the optimal magnification ratiofor determining sperm concentration and motility is about 100 to 200. Insome embodiments, the optimal magnification ratio for determining spermmorphology is about 200 to 300. The thinner the magnifying component,the higher the magnification ratio.

The focal length of the magnifying component can also relate to themagnification ratio. In some embodiments, a magnifying component with amagnification ratio of 100 has a focal length of 2.19 mm. A magnifyingcomponent with a magnification ratio of 156 has a focal length of 1.61mm. A magnifying component with a magnification ratio of 300 has a focallength of 0.73 mm. In some embodiments, the magnifying component has amagnification ratio of at least 30, preferably at least 50. In someembodiments, the focal length of the magnifying component is from 0.1 mmto 3 mm.

FIG. 3 illustrates a sample process for performing testing using thetesting equipment Al with magnifying function illustrated in FIG. 1B. Atstep S110, the specimen 40 to be tested is set in the specimen holdingarea 11. At step S110, the cover 20 is stacked on top the carrier 10,before setting the specimen 40 to be tested in the specimen holding area11 from the specimen receiving port 12. Alternatively, the specimen 40to be tested can be set in the specimen holding area 11 directly first,before the cover 20 is stacked on top the carrier 10. At step S120, thespecimen 40 is rested in the specimen holding area 11 selectively for aperiod of time according to testing requirements of the specimen 40. Atstep S130, an intelligent communication device (e.g., a mobile phone) isattached on the cover 20, and the camera of the mobile phone is alignedwith the magnifying part 30, to use the camera of the mobile phone tocapture a picture or video of the specimen through the magnifying part30. At step S140, an application (APP) running at the mobile phone orother analysis device may be used to perform analysis of the picture orvideo, for obtain testing results.

As illustrated in FIG. 4, a supporting side (such as a protruding part)14 may further be formed on a top of the cover 20 of a testing equipmentA2 at a border of the magnifying part 30. In some embodiments, theprotruding type support structure may be formed on top of the cover 20by the addition of the protruding part 14. When the user attempts to usean intelligent communications device 60 (e.g., a mobile device such as asmart phone or tablet) to capture the image or video of the specimen, aside of the intelligent communications device 60 having a camera 61 maybe secured to the protruding part 14 (along the direction shown by thearrow L1). Thus, the testing equipment A2 allows the user to use theintelligent communications device 60 for capturing the image or video ofthe specimen, and does not require an expensive testing apparatus forrecording the image or video. Furthermore, the height of the protrudingpart 14 can be pre-determined for a best observation distance based onspecification of the camera 61 and the testing equipment A2.

As shown in FIG. 5 and FIG. 6, a testing equipment A3 can include abarrel type base 70 (also referred to as base component). The barreltype base 70 includes a lower barrel base 71 and a upper barrel body 72that can be lifted or descended with respect to the lower barrel base71. The lower barrel base 71 has a lateral insertion port 73 providingan insert position for the cover 20 and the carrier 10 stacked together.An upward lighting device 80 is disposed on a bottom part of the lowerbarrel base 71, to provide illumination to the combination of the cover20 and carrier 10 from the bottom. The upper barrel body 72 can include,e.g., at least one additional magnification lens 74 for furthermagnification.

The upper barrel body 72 can be attached to the lower barrel base 71using a screw thread mechanism such that the upper barrel body 72 thatcan be lifted or descended with respect to the lower barrel base 71 likea screw. In other words, the upper barrel body 72 can be rotated withrespect to the lower barrel base 71 along the arrow L2 directions suchthat the upper barrel body 72 moves up and down along the arrow L3directions with respect to the lower barrel base 71. By adjusting theheight of the upper barrel body 72 with respect to the lower barrel body71, the system adjusts the height of the magnification lens 74 (henchanging the magnification ratio) and the height of the camera 61.

An assembling frame 75 (also referred to as form-fitting frame) may bedisposed at an upper end of the upper barrel body 72. The assemblingframe 75 secures the intelligent communications device 60 at apre-determined position. The assembling frame 75 has a camera alignmenthole 76. The camera 61 of the intelligent communications device 60 canreceive light from the specimen through the camera alignment hole 76.

The camera 61 disposed on current intelligent communications device 60typically only have a digital zoom function. Generally an optical zoomlens is required for testing with a high accuracy. However, the userusing the testing equipment A3 does not need a camera 61 having anoptical zoom lens. The high adjustment function of the testing equipmentA3 provides a flexible solution for aligning the specimen, themagnifying lens, and the camera 61.

FIG. 6 shows the intelligent communications device 60 that has beenassembled and secured onto the assembling frame 75, which is disposed onthe upper barrel body 72. The cover 20 and the carrier 10 containing thespecimen 40 are inserted through the lateral insertion port 73. Theupward lighting device 80 may provide illumination to and increase thebrightness of the specimen.

The upper barrel body 72 or the barrel type base 70 can rotated alongthe directions L2, to adjust the height of the magnification lens 74 andthe camera 61 upwards or downwards along the directions L3. The heightadjustment mechanism enables a function for adjusting the magnificationratio. The camera 61 may capture dynamic videos or static testing imagesof the specimen 40 after magnification. Furthermore, the intelligentcommunications device 60 can user its originally equipped functions tostore the captured videos or images, to transfer the testing images orvideos, and to conduct subsequent processing.

As shown in FIG. 7, a testing equipment A4 with magnifying functionincludes a plurality of magnifying parts 30, 30B, 30C with differentmagnification ratios disposed on the cover 20. The user may shift thecover 20 to align the specimen holding area 11 of the carrier 10 withany of the magnifying parts 30, 30B, 30C with different magnificationratios, in order to obtaining testing results with differentmagnification ratios. By this design, the testing equipment A4 withmagnifying function of a single module can be applied to satisfiesmagnification requirements of multiple testing protocols, without theneed of changing the magnifying part or the cover.

As shown in FIG. 8, a testing equipment A5 with magnifying functionincludes a flexible transparent film 15. The flexible transparent film15 is disposed between the carrier 10 and the magnifying part 30, andcovers the specimen holding area 11. The flexible transparent film 15covers the specimen 40 (in liquid state) such that the specimen 40 in aconfined space. Thus, outside influences due to air, dust and dirt areconfined to a minimum level. Furthermore, the testing equipment A5 mayadjust the focal length by the varying the thickness of the flexibletransparent film 15.

As shown in FIG. 9, the magnifying part 30 of a testing equipment A6with magnifying function is a planar convex lens, and a surface of themagnifying part 30 facing the carrier 10 is a protruding surface.Therefore, an upwardly concave type hollow part 21 is formed at thesurface of the magnifying part 30 facing the carrier 10. A focal lengthparameter H1 is defined by the thickness of the thickest part of themagnifying part 30 of the planar convex lens. As shown in FIG. 10, afocal length parameter H2 of a testing equipment A7 with magnifyingfunction is different than the focal length parameter H1 of FIG. 9.

The focal lengths H1 and H2 may be adjusted by changing thickness of thecover 20 or the size of the curvature of the magnifying part 30. Forexample, the focal length H2 shown in FIG. 10 is greater than the focallength H1 shown in FIG. 9, and is achieved by changing the size of thecurvature of the magnifying part 30. In this way, testing requirementsof various focal lengths may be satisfied by adopting differentmagnifying parts 30.

In some embodiments, the magnifying part 30 can be transparent and therest of the cover 20 can be opaque. In addition, the carrier 10 mayinclude the specimen holding area 11 which is transparent. The remainingof the carrier 10 can be opaque. When the testing operations areperformed on the testing equipment, the light can propagate through thethe specimen holding area 11, the magnifying part 30 such that chance oflight interference in other parts of the device is suppressed.

Referring to FIG. 11, in a testing equipment A8 with magnifyingfunction, the carrier 10 of the testing equipment A8 further includes alight beam auxiliary guiding structure 16 formed at the bottom surfaceof the carrier 10. The carrier 10 can be made of transparent ortranslucent material. The light beam auxiliary guiding structure 16 canbe opaque or include a granular structure, a rough pattern, an engravedpattern, or other suitable structure that scatters the light beamreaching the guiding structure 16. The light beam auxiliary guidingstructure 16 may provide a particular pattern for the entire surface ora partial surface of the cover and the carrier. The light beam auxiliaryguiding structure 16 may also be formed all around the side surfaces ofthe carrier 10.

When the cover 20 and the carrier 10 are stacked and are attached to theintelligent communications device 60 (as illustrated in FIG. 4 forexample), the magnifying part 30 is aligned with the camera 61 of theintelligent communications device 60. In addition, a fill light (notshown) can be disposed near the camera 61 on surfaces of the intelligentcommunications device 60. The light beam provided by the fill light maybe guided to the carrier 10 to illuminate the specimen holding area 11through the cover 20. At the same time, the light beam auxiliary guidingstructure 16 of the carrier 10 may cause the light beam provided by thefill light to scatter, further improving the brightness and illuminationuniformity of the specimen holding area 11.

By disposing the light beam auxiliary guiding structure 16, the testingequipment does not require an additional fill light source to illuminatethe carrier 10. Therefore, cover 20 includes a light-transmissivematerial so that the fill light from of the intelligent communicationsdevice 60 can reach the specimen through the cover 20. In somealternative embodiments, the device does not include a cover 20 and thefill light directly reach the carrier 10 without propagating through thecover 20.

The testing equipment A8 with magnifying function can include a non-slipfilm 92 and a pH test paper 94. The non-slip film 92 is attached on thesupporting side (such as the top side) of the cover 20, and is used tostably dispose the cover 20 to the camera 61 of the intelligentcommunications device 60, as shown in FIG. 4, such that the magnifyingpart 30 is aligned to the camera 61 of the intelligent communicationsdevice 60. Using the non-slip film 92, the positioning of theintelligent communications device 60 relative to the testing equipmentA8 is secured to a pre-determined configuration.

The non-slip film 92 can have an opening aligned to the magnifying part30, so that the non-slip film 92 does not block the light transmittedfrom the specimen through the magnifying part 30 to the camera 61. Thenon-slip film 92 can include a material of, for example, silicon. The pHtest paper 94 can be disposed on the specimen holding area 11 of thecarrier 10, to provide an indication of the pH value of the specimen.The pH test paper 94 may be replaced after the usage.

In addition, the magnifying part 30 and the cover 20 can adopt adetachable design. Thus, the user may select another magnifying part 31different from the magnifying part 30 to replace the original magnifyingpart 30 based on testing requirements. Various magnifying part can beassembled with the cover 20 are assembled to achieve differentmagnification ratios or other optical features.

Now referring to FIG. 12, a testing equipment A9 with magnifyingfunction can further include a specimen collection sheet 42 disposed inthe specimen holding area 11. The specimen collection sheet 42, forexample, has a specimen collection area 42A. The specimen collectionarea 42A can use adhesion or other methods to collect sperms,subcutaneous tissue/cells, parasite eggs and the like solid test bodies.In some embodiments, the specimen collection sheet 42 can serve as aspacer to maintain a distance between the cover 20 and the specimenholding area 11.

Next, referring to FIG. 13, a testing equipment A10 with magnifyingfunction can include an isolation component 98 disposed at the specimenholding area 11 between the carrier 10 and the cover 20. The isolationcomponent 98 can isolate the magnifying part 30 and the testing fluid inthe specimen holding area 11, and prevent the testing fluid fromcontaminating the magnifying part 30. In some embodiments, the isolationcomponent 98 can serve as a spacer to maintain a distance between thecover 20 and the specimen holding area 11. The isolation component 98can be integrated with the cover 20 as a single component.Alternatively, the isolation component 98 can be integrated with thecarrier 10 as a single component.

FIG. 14A is a schematic diagram of a test strip inserted into a meterdevice according to another embodiment of the invention. The test strip5 (also referred to test cartridge) includes a detachable cover 20 and acarrier 10. In other words, a combination of a detachable cover 20 and acarrier 10 (as illustrated in FIG. 1B for example) forms a test strip 5.The test strip 5 in in inserted into a meter device 70 (also referred toas base component) through a lateral insertion port. The meter device 70can include, e.g., components for capturing images of specimen collectedin the test strip 5.

FIG. 14B is a schematic diagram of components of a meter deviceaccording to another embodiment of the invention. The meter device 70includes a lateral insertion port 73 providing an insert position forthe strip 5. The strip 5 includes a carrier 10 and a detachable cover20. The detachable cover includes a magnifying component 30. The meterdevice 70 includes a camera 61 for capturing images or videos of thespecimen holding area of the carrier 10. The camera 61 is aligned withthe magnifying component 30. The meter device further includes a lightsource 80 for provide illumination for the specimen holding area fromthe bottom. The carrier 10 can include transparent or translucentmaterials for light prorogation.

In some embodiments, the meter device 70 can further include a phaseplate for shifting phases of light rays emitted from the specimenholding area. When light rays propagate through the specimen, the speedof light rays is increased or decreased. As a result, the light rayspropagating through the specimen are out of phase (by about 90 degrees)with the remaining light rays that do not propagate through thespecimen. The out-of-phase light rays interfere with each other andenhance the contrast between bright portions and dark portions of thespecimen image.

The phase plate can further shift the phases of the light rayspropagating through the specimen by about 90 degrees, in order tofurther enhance the contrast due to the interference of out-of-phaselight rays. As a result, the light rays propagating through the specimenare out of phase, by a total of about 180 degrees, with the remaininglight rays that do not propagate through the specimen. Such adestructive interference between the light rays enhances the contrast ofthe specimen image, by darkening the objects in the image and lighteningthe borders of the objects.

In some alternative embodiments, such a phase plate can be disposed ontop of the detachable cover 20 of the strip 5. In other words, the phaseplate can be part of the strip 5, instead of part of the meter device70.

FIG. 15 illustrates a sample process of a semen test by device such asthe meter device 70 or the intelligent communications device 60 asillustrated in FIGS. 5 and 14 respectively. At step 1505, the deviceobtains an image (frame) of the specimen. At step 1510, the devicedetermines the sperm concentration based on the image. By analyzing thecolor or the grayscale of the pH strip, at step 1515, the device canfurther determine the pH value of the specimen. Furthermore, the devicecan determine the sperm morphology (1520), sperm capacity (1525) andsperm total number (1530). At step 1540, the device obtains a series ofmultiple frames of the specimen. At steps 1545, 1550 and 1555, thedevice can determine the sperm motility parameters based on the spermtrajectory and determine the sperm motility.

FIG. 16 illustrates a sample process of determining sperm concentration.At 1605, a camera of the meter device 70 or the intelligentcommunications device 60 (“the device”), as illustrated in FIGS. 5 and14 respectively, captures a magnified image of the sperm specimen. Thecaptured image is an original image for the determining the spermconcentration. The device then converts the digital color image intodigital grayscale image, and further divides the digital grayscale imageinto multiple regions.

At step 1610, the device conduct an adaptive thresholding binarizationcalculation on each region, based on the mean value and standarddeviation of the grayscale values of that region. The goal of theadaptive thresholding binarization calculation is to identify objectsthat are candidates of sperms as foreground objects, and to identify therest of the region as background.

Foreground objects in the image after the binarization calculation maystill include impurities that are not actually sperms. Those impuritiesare either smaller than the sperms or larger than the sperms. The methodcan set an upper boundary value and a lower boundary value for the sizesof the sperms. At step 1615, the device conducts a denoising operationon the image by removing impurities that are larger than the upperboundary value or smaller than the lower boundary value for the sperms.After the denoising operation, the foreground objects in the imagerepresent sperms.

The method counts the number of sperms in the image based on the headportions of the sperms. At steps 1620 and 1625, the device conducts adistance transform operation to calculate a minimum distance between theforeground objects and the background, and also identify locations oflocal maximum values. Those locations are candidates of sperm headlocations.

At step 1630, the device conducts an ellipse fitting operation to eachsperm candidate object to reduce false positive candidates that do nothave ellipse shapes and therefore are not sperm heads. Then the devicecounts the total number of remaining positive candidates of sperms, andcalculates the concentration of the sperms based on the volumerepresented by the image. The volume can be, e.g., the area of thecaptured specimen holding area times the distance between the specimenholding area and the bottom of the cover.

In some embodiments, the device can use multiple images of the specimenand calculate concentration values based on the images respectively.Then the device calculates an average value of the concentration valuesto minimize the measurement error of the sperm concentration.

Using a series of images (e.g., video frames) of the specimen, thedevice can further determine the trajectories and motility of thesperms. For example, FIG. 17 illustrates sample sperms such as sperm1705 and sample sperm trajectories such as trajectory 1710 andtrajectory 1720.

FIG. 18 illustrates a sample process of determining sperm trajectoriesand motility. A camera of the meter device 70 or the intelligentcommunications device 60 (“the device”), as illustrated in FIGS. 5 and14 respectively, captures a series of images (e.g., video frames) of thesperm specimen. The device uses the captured series of images fordetermining parameters of sperm motility. In order to determine theparameters of sperm motility, the device needs to track the trajectoryof each sperm in the series of images.

The device converts the digital color images into digital grayscaleimages. The device first identifies the head positions of sperms in thefirst image of the series (e.g., using a method illustrated in FIG. 16).The identified head positions of the sperms in the first image are theinitial positions for the sperm trajectories to be tracked. In someembodiments, the device can use a two-dimensional Kalman filter toestimate the trajectory for the movement of the sperms.

In some embodiments, the two-dimensional Kalman Filter for trackingsperm s_(j) with measurement z_(j)(k) includes steps of:

-   1: Calculate the predicted state {circumflex over (x)}_(s) _(j)    (k|k−1) and error covariance matrix P_(s) _(j) (k|k−1):

{circumflex over (x)} _(s) _(j) (k|k−1)=F(k){circumflex over (x)} _(s)_(j) (k−1|k−1)

P _(s) _(j) (k|k−1)=F(k)P _(s) _(j) (k−1|k−1)F(k)^(T) +Q(k−1)

-   2: Using the predicted state {circumflex over (x)}_(s) _(j) (k|k−1),    the measurement z_(j)(k) and error covariance matrix P_(s) _(j)    (k|k−1), calculate the predicted measurement {circumflex over    (z)}_(s) _(j) (k|k−1), measurement residual v_(s) _(j) (k) and    residual covariance matrix S_(s) _(j) (k):

{circumflex over (z)} _(s) _(j) (k|k−1)=H(k){circumflex over (x)} _(s)_(j) (k−1|k−1)

v _(s) _(j) (k)=z _(j)(k)−{circumflex over (z)} _(s) _(j) (k|k−1)

S _(s) _(j) (k)=H(k)P _(s) _(j) (k|k−1)H(k)^(T) +N(k)

-   3: if v_(s) _(j) (k)^(T)S_(s) _(j) (k)⁻¹v_(s) _(j) (k)<γ and ∥v_(s)    _(j) (k)∥/T≦V_(max) then calculate the Kalman filter gain K_(s) _(j)    (k), updated state estimate {circumflex over (x)}_(s) _(j) (k|k),    and updated error covariance matrix P_(s) _(j) (k|k):

K _(s) _(j) (k)=P _(s) _(j) (k|k−1)H ^(T)(k)S _(s) _(j) (k)⁻¹

{circumflex over (x)} _(s) _(j) (k|k)={circumflex over (x)} _(s) _(j)(k|k−1)+K _(s) _(j) (k)v _(s) _(j) (k)

P _(s) _(j) (k|k)=P _(s) _(j) (k|k−1)−K _(s) _(j) (k)H(k)P _(s) _(j)(k|k−1)

(k|k−1) denotes a prediction of image k based on image k−1, {circumflexover (x)}_(s) _(j) is the state of position and velocity of j-th sperm.P_(s) _(j) is the covariance matrix of the estimation error, Q(k−1) isthe process noise covariance matrix, N(k) is the covariance matrix ofwhite position noise vector, γ is the gate threshold and V_(max) is themaximum possible sperm velocity.

When tracking multiple trajectories of multiple sperms, the method canuse joint probabilistic data association filter to decide the trajectorypaths. The joint probabilistic data association filter determines thefeasible joint association events between the detection targets andmeasurement targets. Feasible joint association events(A_(js)) is therelative probability values between the detection sperm s andmeasurement sperm j. Then the method conducts path allocation decisionsbased on optimal assignment method. A_(jt) is defined as:

$A_{js} = \left\{ \begin{matrix}{{- {\ln \left( {\lambda^{- 1}{f_{s_{j}}\left\lbrack {z_{j}(k)} \right\rbrack}} \right)}},} & {{if}\mspace{14mu} {measurement}\mspace{14mu} {sperm}\mspace{14mu} j\mspace{14mu} {is}\mspace{14mu} {validated}\mspace{14mu} {by}\mspace{14mu} {track}\mspace{14mu} s} \\{\infty,} & {otherwise}\end{matrix} \right.$

λ is the parameter, f_(s) _(j) [z_(j)(k)] is the Gaussian probabilitydensity function of the detection sperms.

Based on the series of frames within a time period, the methodidentifies the trajectory of each sperm, such as the trajectory 1805 asillustrated in FIG. 18. Then the method determines various parameters ofthe sperm mobility based on the trajectories. The parameters include,e.g., curvilinear velocity (VCL), straight-line velocity (VSL),linearity (LIN) and amplitude of lateral head displacement (ALH). Thecurvilinear velocity (VCL) 1810 is defined as a summation of movementdistances within a unit of time. The straight-line velocity (VSL) 1815is defined as a straight-line movement distance within a unit of time.The linearity (LIN) is defined as VSL divided by VCL. The amplitude oflateral head displacement (ALH) 1820 is defined as twice the amplitudeof the lateral displacement of the sperm head relative to the averagepath 1825.

In some embodiments, the curvilinear velocity (VCL) 1810 can be used todetermine the sperm motility. The method can set a velocity thresholdvalue. Any sperms having VCL higher than or equal to the velocitythreshold value are identified as active sperms. The rest of the sperms,which have VCL lower than the velocity threshold value, are identifiedas non-active sperms. The level of motility is the number of identifiedactive sperms divided by the total number of sperms recognized from theimages.

The method can further analyze the sperm morphology. A camera of themeter device 70 or the intelligent communications device 60 (“thedevice”) captures a magnified image of the sperm specimen. The capturedimage is an original image for the determining the sperm morphology.

The method detects the shapes of the sperm candidates based onsegmentation. The method uses the locations of heads of the sperms asthe initial points. Using a segmentation algorithm that relates to theshapes, the method divides the images of the sperms into head portions,neck portions and tail portions. For example, the method can divide thesperms using methods such as active contour model.

Based on the each portions, the method calculates parameters for thevarious portions (such as lengths and widths). A classifier (such assupport vector machine, neural network, convolutional neural network oradaboost) can be trained using training data set includes samples thatare labeled already. After the training, the parameters of the variousportions of the sperms can be fed to the classifier to determine whetherthe sperm has a proper morphology.

Although some of the embodiments disclosed herein apply the disclosedtechnology to sperm test, a person having ordinary skill in the artreadily appreciates that the disclosed technology can be applied to testvarious types of biological specimen, such as semen, urine, synovialjoint fluid, epidermis tissues or cells, water sample, etc.

It will be apparent to those skilled in the art that variousmodifications and variations can be made to the structure of the presentinvention without departing from the scope or spirit of the invention.In view of the foregoing, it is intended that the present inventioncover modifications and variations of this invention provided they fallwithin the scope of the following claims and their equivalents.

1. A device for testing biological specimen, comprising: a samplecarrier including a specimen holding area; a detachable cover placed ontop of the specimen holding area, the detachable cover including amagnifying component configured to align with the specimen holding area;wherein the focal length of the magnifying component is from 0.1 mm to 3mm, and the magnifying component has a magnification ratio of at least30.
 2. The device of claim 1, further comprising: a phase plate forshifting phases of light rays from the specimen holding area.
 3. Thedevice of claim 1, further comprising: a lateral light source disposedon a side of the carrier for providing illumination to the specimenholding area through the carrier, the carrier including a transparent ortranslucent material; or a vertical light source disposed on top of orbelow the carrier for providing illumination to the specimen holdingarea.
 4. The device of claim 3, wherein the sample carrier includes aplurality of light reflecting patterns, light beams from the laterallight source are guided through the carrier and are reflected into thespecimen holding area by the light reflecting patterns.
 5. The device ofclaim 1, wherein a distance between the detachable cover and thespecimen holding area of the sample carrier is from 0.005 millimeter to10 millimeters.
 6. A system for testing biological specimen, comprising:a device of claim 1; a base component including: an insertion port forinserting the device of claim 1 into the base component; and a cameracomponent for capturing the image of the specimen holding area, or aform-fitting frame for securing a mobile device that includes a cameracomponent for capturing the image of the specimen holding area.
 7. Thesystem of claim 6, wherein the base component further includes: a lightsource for providing illumination to the specimen holding area; a lightcollimator for collimating light beams emitted from the light source tothe specimen holding area; and an annular diaphragm between the lightsource and the light collimator for forming a hollow cone of light beamsthat travels through the light collimator and then reaches the specimenholding area.
 8. The system of claim 6, wherein the base componentfurther includes a magnifying lens for further magnifying an image ofthe specimen holding area; and wherein the base component includes anadjustment mechanism for adjusting a distance between the magnifyinglens and the specimen holding area and therefor adjusting amagnification ratio for the image of the specimen holding area.
 9. Amethod for testing sperms, comprising the steps of: obtaining the deviceof claim 1, applying a sperm specimen to the specimen holding area,recording a video or an image of the sperm specimen; determining thesperm count of the sperm specimen based on the at least one frame of therecorded video or the recorded image; and determining the sperm motilityof the sperm specimen based on the recorded video or the recorded image.10. The method of claim 9, further comprising: waiting for apre-determined time period for liquefaction of the sperm specimen beforeapplying the sperm specimen to the specimen holding area.
 11. The methodof claim 9, further comprising; placing a mobile device including acamera component on top of the device such that the camera component isaligned with the magnifying component and the specimen holding area; andreceiving by the mobile device light signal from the sperm specimen inthe specimen holding area via magnification by the magnifying component.12. The method of claim 9, further comprising: illuminating the specimenholding area by a lateral illumination device disposed on a side of thecarrier of the device or a vertical illumination device disposed on topof or below the carrier of the device.
 13. The method of claim 12,further comprising; guiding light beams from the lateral illuminationdevice throughout the carrier made of a transparent or translucentmaterial; and reflecting the light beams to the specimen holding area bya plurality of light reflecting patterns included in the carrier. 14.The method of claim 9, further comprising: inserting the disposabletesting device into a base, the base including a camera component forrecording the video of the sperm specimen, or a form-fitting frame forsecuring a mobile device that includes a camera component for recordingthe video of the sperm specimen.
 15. The method of claim 9, furthercomprising: extracting at least one frame from the recorded video of thebiological specimen; identifying a plurality of sperms from the at leastone frame; and calculating the sperm count based on a number ofidentified sperms and an area recorded by the at least one frame. 16.The method of claim 15, further comprising: analyzing shapes of theidentified sperms; and determining a morphology level based on theshapes of the identified sperms.
 17. The method of claim 9, furthercomprising: extracting a series of video frames from the recorded videoof the sperm specimen; identifying a plurality of sperms from the seriesof video frames; identifying moving traces of the sperms based on theseries of video frames; determining moving speeds of the sperms based onthe moving traces of the sperms and a time period captured by the seriesof video frames; and calculating the sperm motility based on the movingspeeds of the sperms.
 18. The method of claim 9, further comprising:further magnifying the video or the image of the sperm specimen througha magnifying lens.
 19. A method for testing sperms using the system ofclaim 6, comprising: inserting the device into the base component;recording a video of the sperm specimen in the specimen holding area bythe mobile device, the mobile device being secured in the form-fittingframe of the base component; determining a sperm count of the spermspecimen based on the at least one frame of the recorded video; anddetermining a sperm motility of the sperm specimen based on the recordedvideo.
 20. The method of claim 19, further comprising: furthermagnifying the video of the sperm specimen through a magnifying lens.